Kornimate/medical-research-clean huggingface dataset:
internet-delivered trauma-focused cognitive-behavioral therapy as an early intervention after sexual trauma

Conditions: Acute Stress Disorder; Post Traumatic Stress Disorder

Summary: the research aims to assess the practicality and implementation aspects, effectiveness, and processes of change related to condensed internet-delivered prolonged exposure (cipe) administered as an early trauma focused intervention after sexual assault. eligible participants are individuals seeking help at traumamottagning centrum för sexuell hälsa, malmö who have been exposed to sexual assualt in the past two months and exhibit psychological symptoms in response to that.

the study is un-controlled with 30 participants that will undergo a brief trauma-focused internet-based cbt treatment, delivered as a three-week treatment comprising of four modules (psychoeducation/rational, in vivo exposure, imaginal exposure and relapse prevention). the primary outcome is level of symptoms of post traumatic stress rated by the pcl-5. secondary outcomes are level of symptoms of post traumatic stress using the clinician administered ptsd scale version 5 (caps-5) and the international trauma questionnaire (itq), level of depression (phq-9), quality of life (wsas and eq-5d ) dropout rate, rates of inclusion, attrition, adherence,and negative effects. qualitative data using a semi-structured interview will be gathered from participants at the end of the treatment collecting data on participants' views on the treatment, preferences for this type of treatment and how to further improve it. the treatment effects will be evaluated using a within-group design with repeated measurements. participants in the study will be will recruited from patients treated for sexual assault at traumamottagning centrum för sexuell hälsa, malmö.

Eligibility criteria:
inclusion criteria: * experienced trauma in the past two months according to criterion a for ptsd in the dsm-5 (exposed to death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence). * at least mild clinical symptoms assessed using the pcl-5 cut-off \>10 * ≥ 18 years * signed informed consent exclusion criteria: * other serious comorbidity as primary concern (ongoing substance dependence, untreated bipolar disorder, psychotic symptoms, severe depression, borderline personality disorder, high suicidal risk) * unable to read and write in swedish * receiving other psychological trauma-focused treatment * ongoing trauma-related threat (e.g., living with a violent spouse) * not stable dose of antidepressant medication the last two weeks

Keywords: condensed prolonged exposure ptsd internetdelivered trauma early intervention prevention cipe
arterial hypertension related to parp inhibitors (arterib)

Conditions: Cancer

Summary: although parp inhibitors (parpi) have proved effective in treating many cancers, few patients receiving parpi may experience rare but serious (or not) adverse events such as hypertension whose data are scarce. the objective was to investigate reports of hypertension related to parpi, including olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, and fluzoparib using the world health organization's (who) pharmacovigilance database: vigibase.

here, investigators use the world health organization's (who) database of individual safety case reports, to identify cases of hypertension ae related to parpi.

Eligibility criteria:
inclusion criteria: * case reported in the world health organization (who) database (vigibase) of individual safety case reports at the time of the extraction, * patients treated with at least 1 parpi (with atc classification system): olaparib (atc l01xx46), niraparib (atc l01xx54), rucaparib (atc l01xx55), talazoparib (atc l01xx60), veliparib, pamiparib, fluzoparib (none). exclusion criteria: -chronology not compatible between the parpi and adverse event
dp13 - a phase ii study in patients with primary aldosteronism

Conditions: Primary Aldosteronism

Summary: the purpose of the present phase ii study is to determine whether dp13 displays the clinical safety and efficacy profile to support further development in patients with primary aldosteronism.

a phase ii, multi-centre, randomized, parallel group, baseline-and withdrawal-controlled study in patients with primary aldosteronism to determine the dose-dependent efficacy, safety and tolerability of dp13 after a 2-week single-blind placebo run-in period followed by a randomized 8-week double-blind treatment period. after an additional single-blind, 2-week dp13 placebo withdrawal period, patients are switched to standard of care.

Eligibility criteria:
inclusion criteria: patients with a guideline-recommended diagnosis of primary aldosteronism exclusion criteria: patients with primary aldosteronism and * hyperkalemia * prolonged qt intervals * refusal of special contraception measures

Keywords: hyperaldosteronism
ischemic and bleeding outcomes after angiolite stent implantation and an abbreviated dual antiplatelet therapy

Conditions: Coronary Artery Disease

Summary: factorial 2x2, all-comer, multicentre, randomized controlled trial (ratio 1:1:1:1). first, the study will compare (first randomization) the non-inferiority in target lesion failure of angiolite stent versus xience stent family. immediately after the first randomization, the study compares (second randomization) the superiority in bleeding bleeding academic research consortium (barc) 2, 3, or 5 of abbreviated dapt versus standard of care. both primary endpoints will be evaluated at 12 months of follow-up. the study will be open-label for the stent type and the antiplatelet regimen.


Eligibility criteria:
inclusion criteria: * age \>18 - \< 95 years; * presence of one or more coronary artery stenosis of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation. the vessel should have a reference vessel diameter of at least 2.00 mm (no limitation on the number of treated lesions, vessels, or lesion length); * able to provide informed consent and willing to participate in the trial. exclusion criteria: * known intolerance to acetylsalicylic acid, p2y12 inhibitors (clopidogrel, prasugrel, or ticagrelor), sirolimus, everolimus, or chromium-cobalt.; * known severe hepatic impairment child-pug stage c; * prior pci (not related to the study) performed in the last 45 days; * planned non-cardiac surgery during the first month after pci, unless dual antiplatelet therapy is maintained throughout the peri-surgical period; * planned coronary artery bypass graft (cabg) or any other cardiac surgery (valvular for instance) following index pci; * active major bleeding or major surgery within the last 30 days; * known stroke (any type) within the 30 days prior to the randomization; * women of childbearing potential being defined as woman from the onset of menstruation (menarche) until they become postmenopausal, unless they are permanently sterile. a postmenopausal state is clarified as having no menstrual periods for 12 consecutive months without any other medical cause. women who have undergone permanent sterilization methods, including hysterectomy, bilateral salpingectomy, and bilateral oophorectomy, can be enrolled in the study * currently participating in another randomized controlled trial and not yet at its primary endpoint; * life expectancy less than one year due to non-cardiovascular comorbidity.

Keywords: angiolite dual antiplatelet therapy percutaneous coronary intervention
safety and pharmacokinetics of single and multiple dose rifampin in infants

Conditions: Infection

Summary: the purpose of this study is to learn more about the safety and dosing of rifampin in infants.

pharmacokinetics and safety of rifampin will be studied in term and preterm infants who are receiving rifampin per standard of care.

Eligibility criteria:
cohort 1: * suspected systemic infection * infant \< 121 days of age at the time of 1st dose of rifampin administration * sufficient intravascular access (either peripheral or central) to receive rifampin. cohort 2: * receiving rifampin per local standard of care. * infant \< 121 days of age at the time of 1st dose of rifampin administration exclusion criteria: cohort 1: * history of allergic reactions to rifampin * aspartate aminotransferase (ast) greater than 3 times upper limit of normal * alanine aminotransferase (alt) greater than 3 times upper limit of normal * serum creatinine greater than 1.7 mg.dl * urine output \< 0.5 ml/hr/kg over the prior 24 hours * any condition which would make the subject, in the opinion of the investigator, unsuitable for the study cohort 2: * none

Keywords: rifampin infants
predictors of ovarian response during clomiphene citrate ovulation induction in patients with polycystic ovary syndrome

Conditions: Anovulation

Summary: the purpose of this study is to determine whether visceral fat area and other criteria assessed during initial screening could predict the response to ovulation induction with clomiphene citrate (cc) in patients with polycystic ovary syndrome (pcos).

the study was carried out on 150 patients with pcos. initial cc doses were 50 mg daily for 5 days starting on cycle day 3. in the case of an absent response, doses were increased to 100 and 150 mg daily in subsequent cycles. first ovulation with cc was used as the end point.statistical methods distribution of characteristics in patients is presented as the mean ± sd. we used the mann-whitney u test for exploratory comparison of initial parameters between responders and nonresponders. the univariate and multivariate relation with response to cc was assessed using logistic regression analysis. backward stepwise elimination was used for the multivariate logistic analysis of prediction of patients being cra, and p \< 0.10 was used as a cut-off level for elimination of non-significant predictors from the prognostic model. the area under the receiver operating characteristics (roc) curve (auc) was used to assess the discriminative ability of the logistic models. spss with statistical package version 17 (spss inc., chicago, il) and medcalc software version 12.4, (ostend, belgium) were employed for data analysis.

Eligibility criteria:
inclusion criteria: * the study included 150 infertile women(age from 18 to 40 years) with pcos diagnosed by the presence of at least two of the following \[15\]: 1. clinical hyperandrogenism: hirsutism or acne vulgaris and/or biochemical hyperandrogenism (total testosterone \>88 ng/dl or dheas \>275 ug/dl)\[16\]. (2) menstrual and/or ovulatory disturbances, mainly oligomenorrhea (interval between vaginal bleeding \>35 days and \ 6 months). (3) polycystic ovaries as visualized by transvaginal ultrasound (either 12 or more follicles measuring 2-9 mm in diameter or increased ovarian volume \>10 cm3). exclusion criteria: * patients having one or more of these criteria were excluded; age \ 40 years, body mass index (bmi) \ 35 kg/m2, pregnancy, endocrine disorders, systemic disease, current or previous (within the last 3 months) use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction or dopaminergic agents, use of antidiabetes, antiobesity drugs or history of tubal or ovarian surgery.

Keywords: pcos clomiphene citrate amh visceral fat area homa-ir
effects of balance training with gaze stabilization exercises in elderly patients with chronic dizziness

Conditions: Chronic Dizziness

Summary: effects of balance training with and without gaze stabilization exercises on clinical outcomes in elderly patients with chronic dizziness: a randomized controlled trial

in older adults dizziness is a common condition which is associated with repeated falls, fear of falling, depression, anxiety and ultimately loss of independence during activities of daily living. the main objective of this research was to compare the effects of balance training with and without gaze stabilization exercises on clinical outcomes in elderly patient with chronic dizziness.total 64 participants after referral from neurologist were recruited in this study. these participants were randomly assigned into two groups i.e. group a (gaze group) and group b (control group) with 32 participants in each group by sealed envelope method. gaze group performed balance exercises with gaze stability exercises. gaze stability exercises are further classified as adaptation and substitution exercises. adaptation exercises support long term changes with a purpose of decreasing symptoms and maintain postural stability. on the other hand the substitution exercises improving central preprogrammed movement of eyes. basically gaze stability exercises are defined as habituation exercises which reduce the symptoms of provoking stimulus by continuous exposure to it whereas, group b performed balance exercises with saccade eye exercises.balance training includes both static and dynamic balance exercises, aimed to improved balance and postural stability with gradually increasing to challenging task. exercises in balance training included a) single leg balance on firm surface b) heel stand c) marching on firm surface d) toe stand e) tandem walk f) forward and backward walking from normal base of support to weekly progression and training from eyes open to eye close from stable to unstable surface. berg balance scale, disability handicapped inventory and activity specific balance confidence scale were used to measure outcome variables.

Eligibility criteria:
inclusion criteria: * geriatric population * both gender * h/o chronic dizziness with normal vestibular function * h/o age related balance impairment * h/o impaired balance having a berg balance scale (bbs) score between 35-45 * participant have sufficient cognitive and communication skills exclusion criteria: * h/o insufficient communication skills to follow instructions * h/o impaired vestibular function * h/o visual impairment * h/o severe hearing loss * h/o mental disorder that could restrains the ability to concentrate during therapy * h/o other systematic diseases * any history of marked musculoskeletal impairment, lower limb injury, surgery other than age related changes and balance disorder due to other neurological conditions like parkinsonism, stroke, multiple sclerosis etc. were excluded from the study
prophy-vap: prevention of early ventilation acquired pneumonia (vap) in brain injured patients by a single dose of ceftriaxone

Conditions: Early Ventilation Acquired Pneumonia in Brain Injured Patients

Summary: ventilation-associated pneumonia (vap) is the main site of healthcare-associated infections in the brain injured patients, with an incidence rate of 22% to 58%. vap increases morbi-mortality, length of stay in intensive care and overall management costs. the prevention of icu nosocomial infections depends on several measures : orotracheal intubation route, maintaining tube cuff pressure between 25 and 30 cm of water (h2o), maintaining a semi-seated position \>= 30°, nasal and oropharyngeal care at regular intervals, striving to avoid unscheduled extubation, and use of a written sedation-analgesia algorithm allowing for early weaning from ventilation. two randomized study show that administration of antibiotic therapy after intubation reduces the risk of early vap incidence. however, in clinical practice, its administration solely purposes of limiting vap occurence is not presently recommended. indeed, to date no placebo blind controlled study was been realized and the fear of development of bacterial resistance remains stronger than the efficiency of this prevention measure. this aim of the present study is to show by a placebo randomized study that 2g of ceftriaxone within 8 hours post-intubation after a brain injury decrease the risk of occurence an early vap. ancillary study an ancillary study is performed in 2 centres which routinely practice rectal swabs at admission and discharge of icu, to survey intestinal flora (chu of angers and chu of rennes). the goal of this study is to compare the incidence of acquired cephalosporin resistant gram negative bacteria at the discharge of icu between the 2 groups of patients, receiving or not ceftriaxone.


Eligibility criteria:
inclusion criteria: * brain injured patients with a glasgow scale score ≤ 12 who require ventilation more than 48 hours exclusion criteria: * patient with a high risk of death within the 48 first hours after admission, * patient intubated for more than12 hours * intubation after the 48th hours after admission * coverage to cardiopulmonary arrest * coma due to a tumor, an infectious disease or a cardiac arrest * previous hospitalisation within the last month before admission for coma * béta-lactamines allergy * patient who receive already antibiotics at the admission for a previous infection * prophylactic antibiotic due to be done within 24 hours following the randomisation * patient intubated through a tracheal tube with subglottic secretion aspiration * patient with a tracheotomy * patient or family refuse to be involved in the study * use of ceftriaxone within 2 days before enrolment * participation in another research protocol focusing on an anti-infective treatment or on a measure decreasing the risk of infection * patients not affiliated to a social security scheme, pregnant woman or breast-feeding mother, patients deprived of their liberty by judicial or administrative decision
menstrual cycle on injection pain of rocuronium

Conditions: Pain, Menstrual

Summary: this study evaluates the effects of rocuronium injection pain to menstrual cycle phases.half of participants will receive follicular phase, while the other half will receive luteal phase.

menstrual period includes a spectrum of emotional and somatic symptoms observed in luteal phase of menstrual cycle, which are disappeared after menstruation. during menstrual cycle, fluctuation in sexual hormones results in attitude change and alteration in pain perception. different studies reported some interactions between sex hormones and central nervous system, which might be linked to activity of serotonin and beta-endorphin in the brain. pain perception differs during menstrual cycle. it has been recommended that estrogens might have an influence on somatic sensory process. some studies reported a significant effect of pain sensitivity with higher levels of progesterone and some other studies reported similar patterns for pain perception. there are reports of more complaint of pain in luteal phase of menstruation, which is suggested as the reason for functional changes in women during menstrual cycle.

Eligibility criteria:
inclusion criteria: * american society of anesthesiology classification (asa) i-ii * 18-45 years * regular menstrual cycle exclusion criteria: * irregular menstrual cycles * patients receiving hormones or drugs affecting the ovulatory cycle * amenorrhea * pregnancy * climacteric patients
stereotactic radiosurgery in the treatment of essential tremor

Conditions: Essential Tremor

Summary: the goal of this interventional study is to evaluate the effectiveness of treatment using stereotactic radiosurgery in the treatment of essential tremor in adult patients

the study will include patients diagnosed with essential tremor who have insufficient tremor control despite the use of available pharmacotherapy methods. the study will include patients who have been disqualified from the deeply brain stimulation procedure or who do not consent to its performance. additional conditions for the examination are age over 50 and the duration of the disease over 5 years. after qualifying and giving written informed consent, the patient will be randomly assigned to one of two study arms: 1. control arm: patients irradiated with the cyberknife with a dose of 130 gy 2. test arm: patients irradiated with the cyberknife with a dose of 80 gy the primary aim of the study is to determine the effectiveness of radiosurgery in patients with essential tremor. secondary objectives will be to determine the impact of treatment on the quality of life of, as well as to assess the safety and possible complications of radiosurgery.

Eligibility criteria:
inclusion criteria: * essential tremor diagnosed, parkinson's disease and other causes of tremor excluded. * insufficient tremor control despite the use of available pharmacotherapy methods. * disqualification from the deeply brain stimualtion procedure/lack of consent to perform it on the side qualified for stereotactic radiosurgery * consent to participate in a clinical trial. exclusion criteria: * age under 50 * pregnancy * duration of the disease less than 5 years * dementia, psychosis or other condition that prevents giving informed consent to participate in the study * poor general condition, serious comorbidities * structural changes in the basal ganglia or major atrophic changes * previous radiotherapy to the brain covering the potential treatment area * medical contraindications to magnetic resonance imaging

Keywords: tremor stereotactic radiosurgery frameless radiosurgery essenstial tremor cyberknife
comparison of the combination of fenofibrate and simvastatin versus pravastatin

Conditions: Hyperlipidemia

Summary: mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. statins and fibrates have complementary mechanisms and can be coadministered to patients with mixed hyperlipidemia.the overall objective of the study is to compare the efficacy and safety of combining fenofibrate and simvastatin versus pravastatin monotherapy in patients with mixed hyperlipidemia at risk of cardiovascular diseases.


Eligibility criteria:
inclusion criteria: * mixed dyslipidemia exclusion criteria: * known hypersensitivity to fenofibrates or simvastatin or pravastatin * pregnant or lactating women * contra-indication to fenofibrate or simvastatin or pravastatin * unstable or severe cardiac disease

Keywords: hyperlipidemia combined, efficacy combination fenofibrate simvastatin versus pravastatin hyperlipidemia combined
intraopertive hypotension and postoperative cardiovascular complications among chinese elderly patients undergoing oncardiac surgery : a retrospective cohort study

Conditions: Hypotension

Summary: to explore the relationship of intraoperative hypotension and perioperative cardiovascular complications in elderly noncardiac surgical patients


Eligibility criteria:
inclusion criteria: * patients over 65 years * undergoing general anesthesia * inpatients who had noncardiac surgery between january 1, 2012 and august 31, 2019 exclusion criteria: * asa grade v * low-risk surgery (hysteroscopic and body surface surgery) * length of surgery ≤30 min * short operation interval (less than 3 days between procedures) * without intraoperative blood pressure value at 30s intervals * missing data on patient characteristics.
an open-label study to evaluate the long-term safety and tolerability of lum001 in patients with primary biliary cirrhosis

Conditions: Primary Biliary Cirrhosis

Summary: open-label, multicenter study in adults with primary biliary cirrhosis (pbc) designed to evaluate the long-term safety and tolerability of daily dosing with lum001.

this is an open-label study in subjects with pbc who previously completed the lum001 201 (clarity) study. the study is designed to investigate the long-term safety and tolerability of lum001 treatment, with daily dosing for up to 2 years. changes over time, compared to baseline, in liver enzymes, other biochemical markers associated with pbc, pruritus, and other quality of life measures will also be assessed.

Eligibility criteria:
inclusion criteria: 1. completed a core treatment protocol of lum001 in the treatment of primary biliary cirrhosis. 2. ability to understand and willingness to sign informed consent/assent prior to initiation of any study procedures. exclusion criteria: 1. presence of advanced liver disease. 2. history of non-adherence during the subject's participation in the core lum001 treatment protocol.